March 19, 2014 - - EPA published a Federal Register Notice announcing the availability of an electronic reporting option for Substantial Risk Notifications under TSCA section 8(e) and “For Your Information” (FYI) submissions. Read the Federal Register notice.
Section 8(e) of the Toxic Substances Control Act (TSCA) requires U.S. chemical manufacturers (including importers), processors, and distributors to notify EPA immediately of information that reasonably supports the conclusion that their substances or mixtures presents a substantial risk of injury to health or the environment. EPA’s guidance states that Substantial Risk Notifications under TSCA Section 8(e) should be submitted within 30 calendar days of obtaining substantial risk information.
In addition, EPA established a classification system to distinguish voluntary “For Your Information” (FYI) submissions from Substantial Risk Notifications submitted formally to EPA under TSCA Section 8(e), discussed above. The FYI classification was created by EPA to capture chemical risk submissions by persons or organizations not subject to the TSCA Section 8(e) reporting requirements.
This site offers:
- Overview of Substantial Risk Notifications under TSCA Section 8(e)
- "For Your Information" (FYI) Submissions
- Voluntary Risk Management Actions
- How is TSCA Section 8(e) Information Used
- How EPA Evaluates TSCA Section 8(e) and FYI Submissions
- How EPA Corresponds with TSCA Section 8(e) and FYI Submitters
- Public Access to TSCA Section 8(e) and FYI
Overview of Substantial Risk Notifications under TSCA Section 8(e)
Section 8(e) of the Toxic Substances Control Act (TSCA) states:
"Any person who manufactures, processes or distributes in commerce a chemical substance or mixture and who obtains information which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment shall immediately inform the [EPA] Administrator of such information unless such person has actual knowledge that the [EPA] Administrator has been adequately informed of such information."
Note that the definition of manufacture includes import (see definition 7 under Section 2602 of TSCA, referring to 15 USC 2602).
Anyone subject to the TSCA Section 8(e) reporting requirement should submit a report to EPA within 30 calendar days of obtaining the information. This information may be toxicity or exposure data and need not be complete or definitive. Full reports or summarized results may be submitted. Limited studies (e.g., range-finding studies), preliminary results and draft reports may constitute sufficient evidence for TSCA Section 8(e) reporting. Information that has been published or submitted to EPA under other authorities is exempt from TSCA Section 8(e) reporting.
The Agency routinely asks for additional information from submitters and it posts submissions to make them more easily accessible to the public.
"For Your Information" (FYI) Submissions
The “For Your Information” (FYI) submission classification system was established by EPA to distinguish these voluntary submissions from “substantial risk” notifications submitted formally to EPA under TSCA Section 8(e), a mandatory reporting provision of TSCA, discussed above. The FYI classification was created by EPA to capture submissions by persons or organizations not subject to the reporting requirements.
Since 1977, EPA has received FYI submissions covering a wide variety of chemical substances and mixtures from chemical companies, trade associations, unions, public interest groups, civic associations, private citizens, academic institutions, state and other federal agencies as well as similar organizations and agencies in foreign countries. These substantial risk notices contain information on human exposure, epidemiology, toxicity test results, monitoring studies, environmental fate, and other information that may be pertinent to risk assessment.
Sometimes FYIs are submitted when a manufacturer, importer, or processor is not sure its information supports a conclusion of substantial risk. Often they are submitted when a person or company not required to submit, nevertheless, would like to bring risk information on a chemical to EPA’s attention. Chemical companies, trade associations, public interest groups and academic institutions are among those who submit FYIs.
Voluntary Risk Management Actions
EPA's longstanding proactive implementation of TSCA Section 8(e) has resulted in heightened overall chemical industry awareness of risks posed by exposure to chemical substances and mixtures. This heightened awareness has led, in many cases, to specific voluntary pollution prevention and risk reduction activities designed to directly or indirectly protect health and the environment. EPA's TSCA Section 8(e) implementation encourages these voluntary actions to occur earlier than they might otherwise.
Many companies have reported that in direct response to new chemical toxicity or exposure data reported under TSCA Section 8(e) or on an FYI basis, the following types of health and/or environmental protection measures have been initiated on a voluntary basis:
- Notification of workers, customers, others
- Changes to product labels and/or Material Safety Data Sheets (MSDSs) to ensure proper and safe handling
- Additional studies to better determine chemical toxicity or exposure chemicals
- Engineering changes in manufacturing and processing facilities to reduce/eliminate chemical exposure
- Chemical manufacture or use halted temporarily or discontinued altogether
How TSCA Section 8(e) Information is Used
TSCA Section 8(e) data can be used by all levels of government, public interest groups, the chemical industry, the public and other stakeholders to further assess and understand potential human health and environmental risks associated with exposure to chemical substances. Understanding potential risks associated with chemicals is an important component of risk management actions by regulation or by voluntary compliance to reduce risks.
How EPA Evaluates TSCA Section 8(e) and FYI Submissions
EPA screens all TSCA Section 8(e) submissions, as well as voluntary FYI submissions. The purpose of screening is to identify chemicals for further assessment or testing and to refer information of interest to other EPA program offices and others. The unpublished TSCA Section 8(e) and FYI data are used with other information sources for:
- hazard assessment and risk assessment
- chemical advisories
- chemical summaries
- risk management
- pollution prevention through identification of safer substitutes
- determination of testing needs, such as in Screening Information Data Set (SIDS) and the High Production Volume (HPV) Challenge program
- preclusion of unnecessary testing if adequate data are already available
EPA encourages public access to all non-confidential TSCA Section 8(e) and FYI submissions to promote risk assessment and risk management of chemicals.
How EPA Corresponds with TSCA Section 8(e) and FYI Submitters
In addition to acknowledgment letters from the Document Processing Center following receipt of all new TSCA Section 8(e) submissions, EPA routinely requests additional information from TSCA Section 8(e) and FYI submitters when submissions are incomplete or factual errors are suspected. EPA may also request information from submitters to help determine if further assessment is needed. Information most often requested includes chemical identity of test substance, chemical uses, commercial status of mixtures, exposure-related information, and voluntary risk management actions taken to reduce potential health and environmental risks.
Public Access to TSCA Section 8(e) and FYI
Substantial Risk Notifications most often contain toxicity data but they may also provide information on exposure, environmental persistence or actions being taken to reduce human health and environmental risks. Summarized results or full studies assessing acute effects, reproductive and developmental toxicity, carcinogenicity, neurotoxicity, genetic effects are made available to the public as well as epidemiological studies, clinical studies, ecological studies and information on fish another aquatic species.
Copies of TSCA Section 8(e) and FYI submissions are available to the public in the TSCA Public Docket at EPA Headquarters where paper or microfiche copies of all TSCA Section 8(e) and FYI submissions are maintained and can be accessed by visiting the public reading room at EPA Headquarters or by contacting EPA using the information located on the contact us page. New submissions may be available and accessed directly from the biweekly or monthly tabular summaries located on the TSCA Section 8(e) and FYI submissions page.
TSCA Section 8(e) and FYI submissions are also available through the National Technical Information Service (NTIS) of the U.S. Department of Commerce. Telephone: (703) 605-6000.
Information on TSCA Section 8(e) and FYI submissions, but not the submissions themselves, is also available in the Toxic Substances Control Act Test Submission (TSCATS) database.